Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201607001714118 Date of Registration: 14/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ventral hernia repair, comparitive study.
Official scientific title Primary ventral hernia repair; mini-component separation technique versus onlay mesh repair
Brief summary describing the background and objectives of the trial Although the frequency of ventral herniorrhaphy, it is somewhat surprising that the question of optimal choice of repair is not yet settled. The published data of numerous studies revealed results with big differences.The aim of this study to compare the results of mini-component separation technique repair of primary ventral hernia cases with onlay mesh repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery,ventral hernia repair
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 28/02/2012
Actual trial start date 28/02/2012
Anticipated date of last follow up 01/05/2017
Actual Last follow-up date 01/05/2017
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 64
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ventral hernia repair suture repair of ventral hernia 30
Experimental Group Ventral hernia repair mini-component separation technique. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients had primary ventral hernias. included complicated or recurrent hernia cases, chronic liver disease, immune deficiency disease or known use of immunosuppressive treatment and pregnant cases. 33 Year(s) 61 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/02/2012 banha university
Ethics Committee Address
Street address City Postal code Country
banha fareed nada street banha 13518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome surgical site occurence seroma,hematomaand infection.
Secondary Outcome recurrence recurrent bulge.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
banha university hospital banha fareed nada street banha 13518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal authors. banha fareed nada street banha 13518 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor banha university hospital banha fareed nada street banha 13518 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
personal authors. banha fareed nada street banha 13518 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hussein elgohary dr_elgohary1996@yahoo.com 01113543824 banha university hospital
City Postal code Country Position/Affiliation
banha 13518 Egypt Assistant professor of general surgery, faculty of medicine, Benha University.
Role Name Email Phone Street address
Public Enquiries Mostafa baiuomy mostbiomy@gmail.com 01099038922 banha fareed nada street
City Postal code Country Position/Affiliation
banha 13518 Egypt Assistant professor of general surgery, faculty of medicine, Benha University.
Role Name Email Phone Street address
Scientific Enquiries ehab oraby ehaborabyy@yahoo.com 01003783425 banha fareed nada street
City Postal code Country Position/Affiliation
banha 13518 Egypt Lecturer of general surgery, faculty of medicine, Benha University.
REPORTING
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Result URL Hyperlinks
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